Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117200715 | 11720071 | 5 | F | 20151022 | 20160914 | 20151110 | 20160921 | EXP | US-ALEXION PHARMACEUTICALS INC-A201504308 | ALEXION | 47.30 | YR | F | Y | 0.00000 | 20160921 | CN | US | US |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117200715 | 11720071 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | 398.864014 | MG | N | T2-AE1225B01 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | ||
| 117200715 | 11720071 | 2 | C | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Unknown | 50 MG, UNK | 0 | 50 | MG | ||||||||
| 117200715 | 11720071 | 3 | C | TYLENOL | ACETAMINOPHEN | 1 | Unknown | 2 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117200715 | 11720071 | 1 | Paroxysmal nocturnal haemoglobinuria |
| 117200715 | 11720071 | 2 | Premedication |
| 117200715 | 11720071 | 3 | Premedication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117200715 | 11720071 | HO |
| 117200715 | 11720071 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117200715 | 11720071 | Asthenia | |
| 117200715 | 11720071 | Contusion | |
| 117200715 | 11720071 | Fall | |
| 117200715 | 11720071 | Gait disturbance | |
| 117200715 | 11720071 | Infusion related reaction | |
| 117200715 | 11720071 | Iron overload | |
| 117200715 | 11720071 | Oral herpes | |
| 117200715 | 11720071 | Pain | |
| 117200715 | 11720071 | Platelet count decreased | |
| 117200715 | 11720071 | Transfusion reaction |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 117200715 | 11720071 | 1 | 20151022 | 20160414 | 0 |